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II. 1 Quality risk management as part of

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Integrated Quality Management Industry Competent Authorities Quality risk management as part of II.1: Integrated quality management Documentation Training and ... – PowerPoint PPT presentation

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Title: II. 1 Quality risk management as part of


1
II. 1 Quality risk management as part of
  • Integrated Quality Management

Industry
Competent Authorities
2
Quality risk management as part of
  • II.1 Integrated quality management
  • Documentation
  • Training and education
  • Quality defects
  • Auditing / Inspection
  • Periodic review
  • Change management / change control
  • Continual improvement

3
II.1 QRM as Part of integrated Quality Management
  • Documentation
  • To review current interpretations and application
    of regulatory expectations
  • To determine the desirability of and/or develop
    the content for SOPs, guidelines, etc.

ICH Q9
4
Existing document structure
5
Include ICH Q9
Risk-based approach
Consider ICH Q9
Implement risk-based thinking
e.g. FMEA table list of residual risks
Examples for using specific tools
6
Application of documentation system
  • A topic for any quality management system might
    be a risk-based approach for decision making
  • Include consideration of ICH Q9 guideline in the
    directive on Quality Unit-activities as a
    requirement
  • During periodic review of regulations, policies,
    guidelines and standard operating procedures
    (SOP) etc. think about implementing the ICH Q9
    principles
  • Share examples of specific tools and their use as
    a means of sharing best practice

7
II.1 QRM as Part of integrated Quality Management
  • Training and education
  • To determine the appropriateness of initial
    and/or ongoing training sessions
  • Based on education, experience and working habits
  • A periodic assessment of previous training
    (effectiveness)
  • To identify the training, experience,
    qualifications and physical abilities
  • To perform an operation reliably and with no
    adverse impact on the quality of the product

ICH Q9
8
II.1 QRM as Part of integrated Quality Management
  • Quality defects
  • To provide the basis for identifying,
    evaluating, and communicating the potential
    quality impact of a suspected quality defect,
    complaint, trend, deviation, investigation, out
    of specification result, etc.
  • To facilitate risk communications
  • To determine appropriate action to address
    significant product defects, in conjunction with
    regulatory authorities (e.g., recall)

ICH Q9
9
Assess the history of known quality defects
  • Vision
  • Robust Processes, non-recurrent Q-problems
  • Target
  • Continuous improvement to resolve known
    problems e.g. from CAPA, inspections/audits, non
    robust processes
  • Preventatively work towards the achievement of a
    high reliability, productivity, quality of all
    that we do
  • Manage dedicated projects to support site /
    departments / process / products

10
Assess the history of known quality defects
ICH Q9
Site approach
Identification of opportunities for improvement
Use risk assessment tool -risk analysis -risk
evaluation prioritization
Select improvement opportunities
Dedicated projects - Establish a team
Problem solving approach
Risk review re-application of risk assessment
tool
11
Assess the history of known quality defects
  • Approach
  • Increase the knowledge of weaknesses for all
    processes at the site and evaluate the related
    risks
  • Tackle individual issues by problem solving
    methods e.g. root cause analysis, statistics,
    tools
  • Tool
  • Risk Assessment tools select dynamic tool to
    identify which are the most significant problems
    in order to allow identification of priorities
    (e.g. FTA, FMEA, etc.)
  • SixSigma type Project approach for problem
    solving teams on each identified priority

12
Assess the history of known quality defects
  • The project approach
  • Teamwork (inter-departmental teams) possibly
    using a facilitator
  • Select methodology
  • Commit resources appropriate to the project,
    priority and size
  • Problem solving structure
  • Problem Finding Setting
  • Problem Analysis
  • Problem solution identification
  • Sharing with management (communication)
  • Decision making implementation

13
II.1 QRM as Part of integrated Quality Management
  • Deviation / Investigation Report
  • The event triggers a review of quality risk
    management decisions
  • to control or accept risk related to a process
  • to ensure these decisions are still valid based
    on the new learning
  • In detail this could include
  • Initiate Quality Risk Management process
  • Product and process information
  • Define the problem
  • Detailed description of the discrepancy

14
Deviation/ Investigation Report
  • Risk assessment Risk analysis
  • Assessment of effects of the discrepancy
    Examples if applicable
  • Product quality
  • Drug safety
  • Registration files / Marketing authorisation
  • Systems in place
  • Availability of goods potentially insufficient
    stock levels
  • Identification of the root cause

15
Deviation/ Investigation Report
  • Risk assessment Risk evaluation
  • Consequences for other products / batches
  • Systems failure
  • Evaluation of
  • Performed
  • Foreseen actions
  • Measurements

16
Deviation/ Investigation Report
  • Risk Control Risk Reduction/ Mitigation
  • Corrective actions to resolve the discrepancy
  • Corrective actions to avoid a recurrence in the
    future
  • Risk Control Risk Acceptance
  • Conclusions of measures taken
  • Decisions on disposition of the material
  • Define Follow up actions (if applicable)
  • Management summary (if applicable)
  • Date and signature
  • responsible manager
  • approval of QU

17
Deviation/ Investigation Report
  • Risk Communication
  • Frequent interactions (e.g. short daily meeting)
  • Informal meetings
  • Scheduled regular meetings (minutes)

18
Deviation/ Investigation Report
  • Risk Review
  • Follow up of action items
  • Summary and evaluation
  • e.g. Annual Product Review

19
One page Deviation/ Investigation Report
20
Complaint/ Issue Management
  • Initiate Quality Risk Management process
  • Information on the complaint/ issue
  • Product information
  • Risk identification Define the problem
  • Detailed description of the complaint/ issue
  • Risk to patient? Recall needed?
  • Risk communication to central coordination unit

21
Complaint/ Issue Management
  • Risk assessment Risk analysis
  • Assessment of effects of the discrepancy
    Examples if applicable
  • Lot tracing
  • Product quality
  • Patient impact
  • Registration/ Marketing authorisation
  • Systems in place
  • Availability of stock potentially insufficient
    stock levels..
  • Identification of the root cause
  • Risk communication to expert team

22
Complaint/ Issue Management
  • Risk assessment Risk evaluation
  • Consequences for other batches/ products
  • Systems failure
  • Evaluation of
  • Available data
  • Performed actions
  • Foreseen actions
  • Measurements
  • Risk communication to central coordination
    unit involve management, if appropriate

23
Complaint/ Issue Management
  • Risk Control Risk Reduction/ Mitigation
  • Corrective actions to resolve the discrepancy
  • Corrective actions to avoid a recurrence in the
    future
  • Risk Control Risk Acceptance
  • Conclusions of measures taken (management sign
    off)
  • Decisions on disposition of the material
  • Define follow up actions (if applicable)
  • Management summary (if applicable)
  • Date and signature of minutes
  • Risk communication management to decide next
    steps

24
Complaint/ Issue Management
  • Output/ result Risk Communication
  • Internal
  • Sites / Affiliates
  • Informal meetings
  • Address in regular meetings
  • Training sessions
  • External
  • Communicate with Competent Authorities (e.g.
    Field Alert, incident summary)
  • To whom it may concern letters
  • Pharmacies

25
Complaint/ Issue Management
  • Risk Review
  • Follow up of action items
  • Summary and evaluation e.g. Product Quality
    Review, Annual Product Review, follow-up report

26
II.1 QRM as Part of integrated Quality Management
  • Auditing / Inspection
  • To define the frequency and scope of audits
  • Taking into account factors such as
  • Existing legal requirements
  • Overall compliance status and history of the
    company
  • Robustness of a companys quality risk management
    activities
  • Complexity of the site, manufacturing process,
    product and its therapeutic significance
  • Compliance status and history
  • Results of previous audits/inspections
  • Number and significance of quality defects (e.g,
    recall)
  • Results of previous audits/inspections
  • Major changes of building, equipment, processes,
    key personnel
  • Experience with manufacturing of a product (e.g.
    frequency, volume, number of batches)
  • Test results of official control laboratories

ICH Q9
27
Inspections
Risk Communication Risk Review
Start
cGMP/Compliance Inspections
Risk Acceptance (Work Planning)
Risk Identification (Databases)
Risk Analysis Risk Evaluation (Multi-Factorial
Risk Model)
Risk Reduction (Risk Ranking and Filtering)
D.Horowitz, FDA April 2005
28
Scheduling audits A framework
  • How industry might be able to set up a risk-based
    evaluation scheme to assess the need to audit.
  • A similar approach could be used by competent
    authorities (CA) for scheduling inspections.
  • 1. Brainstorm to create a list of manufacturers
    / traders to be audited
  • 2. Evaluate all sources of audit reports from
    competent authorities, competent companies or
    third parties conducted according local and/or
    other GMP-standards (e.g. PIC/S, WHO respective
    VFA, APIC)

S. Rönninger EFPIA TG foreign inspections
Feb.06
29
Scheduling audits A framework
  • 3. Evaluate risk factor according to criteria
    based on managing risk for patients, which can
    (easily) be evaluated and maintained
  • Severity Compliance effects safety efficacy
  • Severity Patient interest effects availability
  • Probability Complexity Drug(medicinal)product,
    API etc.
  • Detectability Audit History frequency of
    audit/inspections

S. Rönninger EFPIA TG foreign inspections
Feb.06
30
Scheduling audits A framework
  • 4. Weighting on to protection of patient
  • See list on following slides - In case of
    different activities take the highest ranking! -
    In case their is nothing known, take the highest
    ranking!

S. Rönninger EFPIA TG foreign inspections
Feb.06
31
Scheduling audits A framework
  • Compliance (Severity) patient risk addressing
    safety efficacy

S. Rönninger EFPIA TG foreign inspections
Feb.06
32
Scheduling audits A framework
  • Compliance (Severity) patient risk addressing
    availability

S. Rönninger EFPIA TG foreign inspections Feb.06
33
Scheduling audits A framework
  • Complexity (Probability)

S. Rönninger EFPIA TG foreign inspections
Feb.06
34
Scheduling audits A framework
  • History (Detectability)

S. Rönninger EFPIA TG foreign inspections
Feb.06
35
Scheduling audits A framework
  • 5. Multiply the factors
  • 6. Sort by overall risk factor
  • 7. Announce audits on a predetermined figure
    e.g. 96

S. Rönninger EFPIA TG foreign inspections
Feb.06
36
Scheduling audits A framework
  • Why 96? Conclude to schedule an audit when,
  • Compliance/Severity Safety Efficacy medium
    (3) or more
  • Compliance/Severity Availability       major
    (4) or more
  • Complexity Probability                      
    indirect use for patient (2) or more
  • History Detectability                          
    3 years ago (4) or more
  • This would result in 3 x 4 x 2 x 4 96

EFPIA TG foreign inspections Feb.06
37
Scheduling audits
  • Result an overview
  • Updating once a year for planning

Weighted factors
Indication for priority
Do not trust in the values only
38
II.1 QRM as Part of integrated Quality Management
  • Periodic review
  • To select, evaluate and interpret trend results
    within the product quality review
  • To interpret monitoring data e.g. to support an
    assessment of the need for revalidation, changes
    in sampling etc.

ICH Q9
39
II.1 QRM as Part of integrated Quality Management
  • Change management / change control
  • To manage changes based on knowledge and
    information accumulated in pharmaceutical
    development and during manufacturing
  • To evaluate the impact of the changes on the
    availability of the final product
  • To evaluate the impact on product quality of
    changes
  • To determine appropriate actions preceding the
    implementation of a change

ICH Q9
40
Responsibilities in case of Change Control
Industry
Regulators
41
II.1 QRM as Part of integrated Quality Management
  • Continual improvement
  • To facilitate continual improvement in processes
    throughout the product lifecycle

ICH Q9
42
Continual Improvement
All red arrows are a part of Risk Communication
Takayoshi Matsumura, Eisai Co.
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